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Selected National Pharmacovigilance Websites

An Analysis of Contents

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Abstract

Background: Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), nationally and internationally. Effective communication, which relies increasingly on the Internet, is a crucial aspect of pharmacovigilance activities.

Aim: The aim of this study was to perform an exploratory survey of national pharmacovigilance websites and compare their contents.

Methods: Of 99 international pharmacovigilance organizations known to us (listed in the Side Effects of Drugs Annual 30), 45 included website addresses and 35 provided some or all of the information in English. We reviewed 10 of these 35 websites in order to identify their contents. The 10 sites that we selected contained the most extensive information on pharmacovigilance of those that we were able to access. Reviewing these sites, we identified 32 items of information that we used to assess the scope of each website systematically, using a scoring system based on the presence or absence of those items.

Results: All the websites gave clear descriptions of national pharmacovigilance requirements and the reporting systems for ADRs, and all included devices. Beyond this, there was great variability in content from site to site. Few websites allowed access to raw pharmacovigilance data, such as individual case reports.

Conclusions: Online drug safety communication from the selected national websites we examined is highly variable from site to site, although a wider study is needed to confirm this. Agreement on the key components of pharmacovigilance websites would facilitate the development of a standardized format to improve online communication.

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Acknowledgements

No sources of funding were used to assist in the preparation of this study. The authors have no conflicts of interest that are directly relevant to the content of this study.

Jeffrey Aronson suggested and oversaw the project; Charlotte Barker accessed the websites and drew up the lists of categories and items; Charlotte Barker and Jeffrey Aronson both searched the websites and analysed the results. Charlotte Barker, John Talbot and Jeffrey Aronson all contributed to the writing of the paper. We are grateful to Ralph Edwards, Stephen Evans and Robin Ferner for helpful discussion and suggestions.

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Authors and Affiliations

  1. Oxford University Clinical Academic Graduate School, Medical Sciences Division, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK

    Charlotte I.S. Barker

  2. University of Hertfordshire, Hatfield, Hertfordshire, UK

    John C.C. Talbot

  3. Department of Primary Health Care, University of Oxford, Oxford, UK

    Jeffrey K. Aronson

Authors
  1. Charlotte I.S. Barker
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  2. John C.C. Talbot
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  3. Jeffrey K. Aronson
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Correspondence to Charlotte I.S. Barker.

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Barker, C.I., Talbot, J.C. & Aronson, J.K. Selected National Pharmacovigilance Websites. Drug Saf 35, 141–148 (2012). https://doi.org/10.2165/11596270-000000000-00000

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